Viewing Study NCT00354497



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Study NCT ID: NCT00354497
Status: UNKNOWN
Last Update Posted: 2013-09-20
First Post: 2006-07-19

Brief Title: Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
Sponsor: Lawrence Livermore National Laboratory at University of California
Organization: National Cancer Institute NCI

Study Overview

Official Title: Prostate Cancer Screening and Dietary HA Exposure in African-Americans Phase II
Status: UNKNOWN
Status Verified Date: 2008-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Screening may help doctors find prostate cancer sooner when it may be easier to treat The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer

PURPOSE This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men
Detailed Description: OBJECTIVES

Estimate dietary heterocyclic amine HA exposure in African American men who use HA-forming meats and cooking methods
Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results ie higher HA exposure with increased abnormality in prostate cancer screening results in these participants

OUTLINE This is a prospective study

Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption cooking preferences and other factors that may be associated with prostate cancer risk Participants then undergo a digital rectal exam DRE and blood collection for prostate-specific antigen PSA testing total PSA and free PSA Results of PSA testing and DRE including follow-up instructions if needed are sent to the participant 3-4 weeks later

Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity

PROJECTED ACCRUAL A total of 800 participants will be accrued for this study

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
LLNL-05-104 None None None